PROPONENT SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PROPONENT SR SL (Model L200)
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
GTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025, 709037, 709040, 709041, 710248, 710517, 710627, 710705, 710754, 710765, 710771, 710772, 710788, 710789, 710790, 710824, 710825, 710831, 710889, 710905, 710907, 710910, 710916, 710931, 710954, 710980, 711315, 711412, 711640, 711655, 714062, 714644, 714688, 714708, 715328, 717903, 717931, 717934, 717941, 717948, 717950, 717951, 717965, 717976, 717981, 717982, 717992, 718007, 718009, 718138, 718522, 718780, 718783, 718937, 720309, 720504, 720556, 720597, 720650, 721983, 721991, 722012, 722438, 722565, 722689, 722724, 722756, 722967, 723456, 724170, 724319, 724398, 724404, 724485, 724623, 725175, 725182, 725198, 725262, 725272, 725283, 725363, 725365, 725368, 725370, 725371, 725372, 725373, 725383, 725388, 725389, 725390, 725392, 725404, 725409, 725418, 725419, 725425, 725444, 727098, 728855, 728893, 728894, 728917, 728922, 729054, 729410, 729411, 729413, 729421, 729589, 729599, 729602, 731110, 731612, 734834. GTIN 00802526578007, Serial Numbers: 464370, 464388, 464446, 464452, 464458, 464460, 464467, 464468, 464470, 464475, 464477, 464481, 464482, 464483, 464486, 464490, 464491, 464492, 464498, 464500, 464501, 464506, 464508, 464512, 464516, 464519, 464523, 464526, 464528, 464532, 464563, 464568, 464570, 464590, 705011, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705576, 705584, 705622, 705628, 705702, 705706, 705711, 705713, 705728, 705751, 705753, 705795, 705812, 706007, 706098, 706215, 706321, 706350, 706372, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708261, 708473, 708494, 708504, 708528, 708534, 708546, 708549, 708585, 708589, 708595, 708629, 708652, 708657, 708721, 708722, 708723, 708749, 708750, 708752, 708770, 708774, 708775, 708776, 708780, 708797, 708798, 708802, 708815, 708819, 708820, 708831, 708832, 708841, 708843, 708844, 708848, 708851, 708853, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 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719252, 719253, 719255, 719261, 719265, 719270, 719271, 719301, 719357, 719367, 719372, 719373, 719376, 719379, 719421, 719453, 719456, 719460, 719730, 719752, 719753, 719754, 719755, 719756, 719759, 719761, 719894, 719925, 719929, 719943, 719969, 719972, 720012, 720019, 720109, 720110, 720119, 720122, 720124, 720132, 720134, 720135, 720141, 720142, 720144, 720145, 720147, 720150, 720154, 720172, 720173, 720183, 720184, 720191, 720198, 720228, 720234, 720240, 720242, 720250, 720502, 720503, 720538, 720541, 720593, 720600, 720604, 720611, 720618, 720633, 720641, 720660, 720663, 720697, 720729, 720767, 720782, 720792, 720793, 720801, 720832, 720858, 720859, 720874, 720920, 720931, 720943, 720961, 720981, 721004, 721204, 721205, 721213, 721219, 721228, 721230, 721276, 721812, 721872, 721884, 721977, 722030, 722046, 722047, 722178, 722180, 722181, 722333, 722448, 722479, 722539, 722558, 722569, 722570, 722578, 722580, 722612, 722639, 722655, 722668, 722671, 722703, 722705, 722808, 722822, 722843, 722844, 722905, 722906, 722910, 722917, 722921, 722930, 722933, 722944, 722945, 722947, 722948, 722949, 722957, 722958, 722962, 722963, 722964, 722965, 722968, 722969, 722970, 723010, 723298, 723305, 723317, 723580, 723713, 723745, 723749, 723751, 723755, 723766, 723772, 723775, 723777, 723779, 723782, 723784, 723794, 723802, 723830, 724358, 724397, 724400, 724436, 724443, 724448, 724456, 724471, 724496, 724500, 724739, 725060, 725063, 725073, 725074, 725077, 725078, 725083, 725086, 725088, 725100, 725102, 725108, 725112, 725115, 725121, 725132, 725156, 725165, 725179, 725193, 725200, 725202, 725247, 725266, 725270, 725273, 725274, 725275, 725276, 725277, 725279, 725281, 725285, 725288, 725289, 725290, 725291, 725296, 725298, 725300, 725302, 725304, 725305, 725306, 725307, 725308, 725309, 725312, 725322, 725339, 725367, 725386, 725407, 725449, 725459, 725460, 725484, 725659, 725697, 725699, 725703, 725704, 725706, 725710, 725742, 725747, 725750, 725753, 725755, 725756, 725757, 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728558, 728634, 728666, 728677, 728846, 728849, 728850, 728851, 728854, 728919, 728926, 728944, 729047, 729050, 729057, 729059, 729060, 729062, 729065, 729134, 729136, 729138, 729141, 729155, 729157, 729166, 729170, 729187, 729206, 729211, 729414, 729417, 729436, 729438, 729451, 729456, 729513, 729524, 729568, 729573, 729575, 729576, 729632, 729634, 729635, 729637, 729640, 729655, 729656, 729659, 729661, 729685, 730227, 730349, 731139, 731159, 731183, 731184, 731189, 731208, 731210, 731217, 731224, 731228, 731239, 731241, 731249, 731296, 731331, 731332, 731337, 731342, 731343, 731351, 731364, 731368, 731370, 731408, 731415, 731423, 731439, 731452, 731453, 731455, 731462, 731466, 731468, 731471, 731634, 731669, 731773, 731781, 731800, 731815, 731824, 731830, 731878, 731886, 731888, 731932, 731967, 731970, 731972, 731974, 731980, 731986, 731992, 731999, 732280, 732321, 732430, 732436, 732682, 732694, 732749, 732898, 732903, 732913, 733412, 733461, 733496, 733499, 733501, 733533, 733535, 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Products Sold
GTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025, 709037, 709040, 709041, 710248, 710517, 710627, 710705, 710754, 710765, 710771, 710772, 710788, 710789, 710790, 710824, 710825, 710831, 710889, 710905, 710907, 710910, 710916, 710931, 710954, 710980, 711315, 711412, 711640, 711655, 714062, 714644, 714688, 714708, 715328, 717903, 717931, 717934, 717941, 717948, 717950, 717951, 717965, 717976, 717981, 717982, 717992, 718007, 718009, 718138, 718522, 718780, 718783, 718937, 720309, 720504, 720556, 720597, 720650, 721983, 721991, 722012, 722438, 722565, 722689, 722724, 722756, 722967, 723456, 724170, 724319, 724398, 724404, 724485, 724623, 725175, 725182, 725198, 725262, 725272, 725283, 725363, 725365, 725368, 725370, 725371, 725372, 725373, 725383, 725388, 725389, 725390, 725392, 725404, 725409, 725418, 725419, 725425, 725444, 727098, 728855, 728893, 728894, 728917, 728922, 729054, 729410, 729411, 729413, 729421, 729589, 729599, 729602, 731110, 731612, 734834. GTIN 00802526578007, Serial Numbers: 464370, 464388, 464446, 464452, 464458, 464460, 464467, 464468, 464470, 464475, 464477, 464481, 464482, 464483, 464486, 464490, 464491, 464492, 464498, 464500, 464501, 464506, 464508, 464512, 464516, 464519, 464523, 464526, 464528, 464532, 464563, 464568, 464570, 464590, 705011, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705576, 705584, 705622, 705628, 705702, 705706, 705711, 705713, 705728, 705751, 705753, 705795, 705812, 706007, 706098, 706215, 706321, 706350, 706372, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708261, 708473, 708494, 708504, 708528, 708534, 708546, 708549, 708585, 708589, 708595, 708629, 708652, 708657, 708721, 708722, 708723, 708749, 708750, 708752, 708770, 708774, 708775, 708776, 708780, 708797, 708798, 708802, 708815, 708819, 708820, 708831, 708832, 708841, 708843, 708844, 708848, 708851, 708853, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 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Boston Scientific Corporation is recalling PROPONENT SR SL (Model L200) due to Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Recommended Action
Per FDA guidance
Boston Scientific issued an "Urgent Medical Device Correction" notice to its customers on 08/18/2025 via letter. The notice provides an update to the December 2024 customer communication regarding the potential for the ACCOLADE family of pacemakers to initiate Safety Mode due to a high battery impedance state and contains recommendations timely upgrade of pacemaker software to prevent the occurrence of Safety Mode in an ambulatory setting. On 09/05/2025 an update to the 08/18/2025 notice (via letter), superseding the prior notice to address two unintended behaviors associated with the Model 3869 v2.04 software (designed to prevent potential initiation of Safety Mode due to a high battery impedance condition). The behaviors are: 1. Incomplete disablement of wandless automatic telemetry after detecting a high battery impedance condition. If an ACCOLADE family device with an elevated battery impedance induced Code-1003 remains in service, the software s new telemetry activated battery test is designed to continue assessing battery impedance and disable all wandless telemetry operation before high impedance is achieved and device resets can initiate Safety Mode. 2. Potential for the software s new daily battery test to misinterpret measurements in the presence of a magnet, initiating a false positive response that results in disablement of wandless telemetry sessions. For patients monitored via LATITUDE, this will trigger an alert message indicating an erroneous explant indicator (e.g., explant indicator was reached January 1, 2000) if the device had not previously reached replacement indication, stating that LATITUDE is no longer available, and prompting to contact Technical Services. Patients were notified regarding battery performance. Advisory is published at www.BostonScientific.com/advisory. If you have any questions, contact US Technical Services at 1.800.CARDIAC (227.3422) or email to: tech.services@bsci.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026